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FDA 510(k)

CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI

K-Number: K983004 · 1998-11-25

ApplicantHayes Medical, Inc.
Decision Date1998-11-25
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI is the device name listed in this FDA 510(k) record. The listed applicant is Hayes Medical, Inc.. It received FDA 510(k) clearance on 1998-11-25 under 510(k) number K983004. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI?

CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI is a medical device that received FDA 510(k) clearance on 1998-11-25. The listed applicant is Hayes Medical, Inc.. The 510(k) number is K983004.

When did CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI receive FDA 510(k) clearance?

CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI received FDA 510(k) clearance on 1998-11-25, under 510(k) number K983004.

Who is the listed applicant for CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI?

The FDA 510(k) record lists Hayes Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI?

The FDA product code for CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI is JWH.

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Other records listing Hayes Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTK062383UNISYN HA PLASMA MODULAR HIPK060635CONSENSUS ACETABULAR SHELL SYSTEMK030151CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEMK030205CONSENSUS UNIPOLAR HEAD, COCRK021466CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE

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Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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